Eli Lilly Canada Inc. („Lilly“) announced that it received a positive Canada’s Drug Agency (CDA-AMC, formally known as CADTH) recommendation for the Verzenio® (abemaciclib) expanded indication in early breast cancer (EBC) for the full intention-to-treat (ITT) population.
Subsequently, Lilly and the pan-Canadian Pharmaceutical Alliance (pCPA) successfully concluded the negotiations for Verzenio’s expanded indication on October 25th, 2024.
This milestone represents a significant advancement in our ongoing commitment to providing innovative treatment options for EBC patients in Canada who have been diagnosed with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, EBC at high risk of disease recurrence based on certain clinicopathological features.
Verzenio® is indicated in combination with endocrine therapy (ET), for the adjuvant treatment of adult patients with HR+, HER2-, node-positive, EBC at high risk of disease recurrence based on clinicopathological features, as defined by the presence of four or more positive nodes, or one to three positive nodes and at least one of the following: a tumour of ≥5 cm, histological grade 3 disease, or Ki-67 score ≥20%. This indication represents a broader population of patients than what was initially approved by Health Canada for EBC in 2022.
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